Status:
UNKNOWN
Phase I Study of Individualized Neoantigen Peptides in the Treatment of EGFR Mutant Non-small Cell Lung Cancer
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Tianjin Hengjia Biotechnology Development co., LTD
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
Brief Summary
Neoantigen vaccine is a new field of research in tumor immunotherapy, and some studies have been conducted with success on Melanoma and glioblastoma. Nearly 80% of lung cancers are diagnosed in an adv...
Detailed Description
This is a phase I clinical study of individualized neoantigen peptides in the treatment of EGFR mutant non-small cell lung cancer aimed to evaluated the safety and immune response of the neoantigen va...
Eligibility Criteria
Inclusion
- Histologically confirmed locally advanced or metastatic non-small-cell lung cancer (stage III or stage IV), with disease progression after surgery and standard chemotherapy.
- With EGFR-TKI sensitive mutations and progresses after receiving EGFR-TKI treatment.
- The first neoantigen treatment is more than 4 weeks away from the previous chemotherapy or clinical research drug treatment.
- The first neoantigen treatment is more than 4 weeks away from the previous radiotherapy or EGFR-TKI treatment.
- At least one measurable disease according to RECIST v1.1.
- 18 years of age or older
- Life expectancy of at least 3 months.
- ECOG Performance Status 0 or 1.
- Have adequate organ function, as measured by laboratory values: Lymphocyte ratio\>20%; WBC\>3.0×10\^9/L; alanine aminotransferase(ALT) and aspartate aminotransferase (AST)≤2.5 × ULN; If the patient has liver metastases, ALT and AST≤5 × ULN; Alkaline phosphatase（ALP）≤2.5 × ULN; total serum bilirubin (TBIL) \< 1.5 × ULN; Urea nitrogen（BUN）≤1.5 × ULN; Creatinine（Cr）≤ULN; Normal blood coagulation function, urine routine, and electrocardiogram (ECG).
- Available tumor specimen for sequencing and EGFR gene mutation frequency\>5%.
- Ability to find more than 3 available neoantigen epitopes.
- No previous immunotherapy, including anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or targeting another stimulatory or co-suppressive T cell receptor (eg CTLA-4, OX-40, CD137 ) drug therapy, peptide / mRNA neoantigen immunotherapy and cell therapy.
- Ability to follow research and follow-up procedures.
- Able to understand and willing to sign an IRB approved written informed consent document.
Exclusion
- Suffering from other known malignant tumors, which are progressing or require active treatment within the past 5 years.
- History of immunodeficiency disorder or autoimmune condition requiring active immunosuppressive therapy.
- Actively infectious condition including hepatitis; HIV antibody positive; Treponema pallidum antibody positive.
- With uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage.
- Known, active, untreated CNS metastasis and / or cancerous meningitis.
- Mental illness or substance abuse disorder, which will interfere with the cooperation with research requirements.
- Evidence of Liver and kidney dysfunction, severe heart disease, coagulation dysfunction and damage to hematopoietic function.
- Receive systemic cytotoxic chemotherapy or test drugs for metastatic NSCLC (excluding EGFR-TKI) within the past month.
- Receive radiotherapy within 2 weeks before the start of neoantigen treatment or chemotherapy within 4 weeks. Participants must recover from all radiochemotherapy-related toxicity without the use of corticosteroids and have not had radiation pneumonitis. Palliative radiotherapy allowed for symptom control must be completed at least 2 weeks before the first medication, and no additional radiotherapy is planned for the same lesion.
- Patients participated in other anticancer drug clinical trials within 4 weeks
- A psychiatric illness/social situations that would limit compliance with study requirements as determined by the investigator from the medical history, physical exam, and/or medical record or the investigator believes that there are other reasons that are not suitable for inclusion.
- Pregnant and/or breastfeeding.
Key Trial Info
Start Date :
May 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04397926
Start Date
May 30 2020
End Date
December 30 2022
Last Update
June 11 2020
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060